FDA considers an application for at-home flu vaccine approval

On Tuesday, AstraZeneca announced that the US Food and Drug Administration is currently reviewing an application regarding the possibility of allowing self-administration of the nasal spray flu vaccine, FluMist. 

Since its introduction to the US market in 2003, FluMist has remained the sole nasal spray option for flu prevention. 

AstraZeneca has petitioned the FDA to grant authorization for self-administration, proposing that adults aged 18 to 49, and even children as young as 2, be permitted to administer the vaccine themselves at home. 

This request is supported by a “usability study” demonstrating that individuals can successfully self-administer the vaccine without the need for a healthcare professional’s presence. If granted approval, this would mark the first instance of a flu vaccine being designated for self-administration.

Under this potential arrangement, patients would still be required to use an online pharmacy system to procure the vaccine, which would subsequently be delivered to their homes in temperature-controlled packaging. 

The objective is to make the flu vaccine more accessible, as the US Centers for Disease Control and Prevention recommends an annual seasonal flu vaccine for everyone aged 6 months and older, yet fewer than half of Americans currently receive this vaccination.

AstraZeneca anticipates that the FDA will reach a decision regarding the self-administration of FluMist within the first quarter of the upcoming year. 

If the FDA approves this change, AstraZeneca plans to offer FluMist for self-administration during the 2024-2025 flu season. Furthermore, it will continue to be available through conventional channels, including administration by healthcare providers at doctor’s offices and pharmacies.

Physicians have expressed their support for the potential increase in accessibility of the flu vaccine through self-administration, although they do not anticipate a significant change in vaccination rates if this approval is granted.

“One of the things we’ve learned from the pandemic is that actually people can do things for themselves, they can take maybe more responsibility for their own health care in their own hands than perhaps we realized or even thought possible,” AstraZeneca’s head of US medical affairs, vaccines and immune therapies, said in an interview.